BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3983009 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14002
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EITHER FELT NO STIMULATION OR ¿VERY HARD¿ STIMULATION. IT WAS NOTED THE STIMULATION DID NOT HAVE A ¿SOFT START.¿ IT WAS REPORTED THE ISSUE STARTED THE DAY OF THE CALL. IT WAS REPORTED THE PATIENT HAD TO RECHARGE EVERY TWO TO THREE DAYS; THE PATIENT WAS USED TO CHARGING ONCE A WEEK. IT WAS NOTED THE PATIENT WAS SCHEDULED FOR A REPROGRAMMING APPOINTMENT ON 2014-07-18. IT WAS REPORTED THE PATIENT HAD LESS THAN FIFTY PERCENT PAIN RELIEF. IT WAS NOTED THE STIMULATION WAS SOMETIMES UNCOMFORTABLE. IT WAS REPORTED THE PATIENT WAS REPROGRAMMED TO IMPROVE THERAPY COVERAGE IN LEFT FOOT AND TOES WHILE MAINTAINING BILATERAL HIP AND LEFT LEG COVERAGE. IT WAS NOTED THE PATIENT WANTED ADAPTIVE STIMULATION DISABLED AS THEY PREFERRED TO MAKE MANUAL ADJUSTMENTS. IT WAS REPORTED THE PATIENT NO LONGER HAD UNCOMFORTABLE STIMULATION OR STIMULATION LOSS. IT WAS NOTED NO ELECTRODES HAD OUT OF RANGE IMPEDANCES. IT WAS REPORTED THE PATIENT WAS ABLE TO DEMONSTRATE EFFECTIVE CHARGING WITH FULL COUPLING. IT WAS NOTED THE PATIENT WAS RECHARGING FOR 2.2 HOURS EVERY 2.9 DAYS. IT WAS REPORTED THE PATIENT WAS HAPPY AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461509 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR